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WO1999021527A1 - Sachet de perfusat ophtalmique et de fluide nettoyant conditionne - Google Patents

Sachet de perfusat ophtalmique et de fluide nettoyant conditionne Download PDF

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Publication number
WO1999021527A1
WO1999021527A1 PCT/JP1998/004814 JP9804814W WO9921527A1 WO 1999021527 A1 WO1999021527 A1 WO 1999021527A1 JP 9804814 W JP9804814 W JP 9804814W WO 9921527 A1 WO9921527 A1 WO 9921527A1
Authority
WO
WIPO (PCT)
Prior art keywords
solution
bag
perfusion
chamber
package
Prior art date
Application number
PCT/JP1998/004814
Other languages
English (en)
Japanese (ja)
Inventor
Katsuhiro Inada
Mitsuhira Nishio
Yoshiyuki Kimura
Junji Kaga
Koichi Muraoka
Nobuaki Sumiyoshi
Seiichiro Iguchi
Hiroaki Yamamoto
Original Assignee
Otsuka Pharmaceutical Factory, Inc.
Senju Pharmaceutical Co., Ltd.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Otsuka Pharmaceutical Factory, Inc., Senju Pharmaceutical Co., Ltd. filed Critical Otsuka Pharmaceutical Factory, Inc.
Priority to DE69840003T priority Critical patent/DE69840003D1/de
Priority to CA002307162A priority patent/CA2307162C/fr
Priority to EP98950367A priority patent/EP1033124B1/fr
Priority to US09/530,507 priority patent/US6764481B1/en
Publication of WO1999021527A1 publication Critical patent/WO1999021527A1/fr
Priority to HK01100886A priority patent/HK1033257A1/xx
Priority to US10/735,639 priority patent/US7047708B2/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10—Bag-type containers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/1462—Containers with provisions for hanging, e.g. integral adaptations of the container
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007—Methods or devices for eye surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/16—Holders for containers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/202—Separating means
    • A61J1/2024—Separating means having peelable seals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2093—Containers having several compartments for products to be mixed

Definitions

  • the present invention relates to an eye perfusion, a washing solution bag package, and more particularly, a solution containing bicarbonate ion and glutathione and Z or dextros used for intraocular and extraocular perfusion during eye surgery, irrigation, etc.
  • a bag package that stably accommodates the components for mixing and adjusting the components in a multi-chamber bag, especially the PH change due to the generation of carbon dioxide in the above liquid can be visually confirmed by the color tone change.
  • the present invention relates to the above-mentioned improved package provided with a pH indicator.
  • Opegard manufactured by Senju Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Ltd.
  • Opegard is used for intraocular and extraocular perfusion and cleaning during ophthalmic surgery such as cataract surgery, vitreous surgery, and glaucoma surgery.
  • Kogyo Co., Ltd. and “BSS Plus”
  • the former operad is adjusted to a liquid form with a pH of 7.2 to 8.2 containing dextroth as one of the active ingredients, but the dextrode is acidic. As it is stable in the region, it has the disadvantage of lacking long-term storage stability.
  • the latter BS Plus is composed of a solution (10 ml or 20 ml) containing oxyglutathione, dextroth, canoleum and ion, and a diluent containing bicarbonate ion. (240 m1 or 480 m1) in a separate glass vial, and use a solution containing oxyglutathione etc. using a transfer device with a double-ended needle at the time of use.
  • the above-mentioned BSSP can be stored stably for a long period of time, when it is used, it requires a transfusion procedure according to the following (1 ') to (4), and accompanying this, for example, the following (a) ) To (f).
  • this type of eye perfusion and cleaning solution in addition to the above-mentioned operad and BSSP, is generally in the form of a liquid contained in a glass vial. It is adjusted to the near alkaline area. If filled in a glass container and then sterilized by heating and stored, there is a fatal disadvantage that glass flakes are generated over time. Therefore, there is a need in the art for the development of a new eye perfusion and lavage solution that replaces the conventional eye perfusion and lavage solution and eliminates all of the drawbacks noted by the authors.
  • bicarbonate ion used in this kind of eye perfusion and irrigation fluid is expressed by the following formula (1)
  • the tears of a healthy person are in the range of pH 7.5 soil 0.2 when awake, and about 7.25 when the eyelids are closed for a long time. If the pH is out of the pH range, for example, pH 6 or lower, or higher than 8, the person feels discomfort. Therefore, it is necessary to keep the eye perfusion and the washing solution within the above range as much as possible. ⁇ ⁇ rise outside this range Etc. must be protected as much as possible.
  • glass containers are easily broken, very heavy, and have the fatal drawback of disposal, and in addition to avoiding the generation of carbon dioxide gas during eye perfusion and heat sterilization of the cleaning solution described above.
  • the generated gas raises the container's internal pressure, which may cause damage to the glass container.
  • the eye perfusion and irrigation solution containing bicarbonate ions preferably has a weak alkaline property in which the pH is in the range of about 7 to 8, as described above.
  • the pH is in the range of about 7 to 8, as described above.
  • an object of the present invention is to solve the above-mentioned drawbacks in the prior art, and to stably store an eye perfusion and irrigation solution containing bicarbonate ions together with oxyglutathione and Z or dexrose for a long period of time,
  • the inventors of the present invention have provided a package.
  • a drug solution containing bicarbonate ions and a drug solution or solid containing oxyglutathione and / or dextroth are sealed in each chamber of a gas-permeable plastic multi-chamber bag and sterilized by high-pressure steam and hot water. Sterilize by a general sterilization method such as immersion sterilization or hot water shower sterilization, or aseptically enclose each in a plastic double-chamber bag, and then use the obtained knob. If the bag is wrapped with a gas-impermeable plastic wrapping material and the space between the bag and the packing material is in a carbon dioxide atmosphere, the chambers of the bag should be connected when used. Thus, it was found that the contents of the bag can be mixed to adjust the eye perfusion and the washing solution, and thus one of the above-mentioned objectives can be achieved.
  • the present inventors wrapped the plastic double-chamber bag with a gas-impermeable plastic packing material, and specified a specific pH indicator in the space between the double-chamber bag and the packaging material.
  • a gas-impermeable plastic packing material specified a specific pH indicator in the space between the double-chamber bag and the packaging material.
  • a multi-chamber bag made of gas-permeable plastic is packaged with a gas-impermeable plastic packaging material.
  • the multi-chamber bag is a drug solution containing at least one selected from oxyglutathione and dextrose (hereinafter referred to as “GSSG / GLU solution”) or a solid agent (hereinafter “GSSG / GLS solution”). / GLU solid agent) and room B containing a chemical solution containing bicarbonate ions (hereinafter referred to as “bicarbonate solution”).
  • GSSG / GLU solution oxyglutathione and dextrose
  • GSSG / GLS solution a solid agent
  • room B containing a chemical solution containing bicarbonate ions
  • An eye perfusion and cleaning solution bag package is provided, wherein the space between the chamber bag and the packaging material is a carbon dioxide gas atmosphere.
  • a package in which a gas-permeable plastic double-chamber bag is packed with a gas-impermeable plastic packaging material, wherein the double-chamber nosog is a GSSGZGLU liquid or a GSSGZGLU solid agent. And the B room filled with bicarbonate ion liquid, and the space between the bag and the packaging material is a carbon dioxide gas atmosphere. And a PH indicator in which a liquid containing bicarbonate ions and a pH indicator that changes color according to a pH change of the liquid are sealed in a small gas-permeable plastic container in the space.
  • the present invention provides an eye perfusion and irrigation liquid bag package characterized in that a single container is disposed.
  • eye perfusion and irrigation solution bag package according to the following aspects.
  • An eye perfusion and washing bag package in which an oxygen detector is placed in the space between the multi-chamber bag and the packaging material.
  • Room A contains GSSG_GLU solid preparation and at least one solid preparation selected from calcium salts and magnesium salts, and preferably also contains a solid preparation containing both of them. Packaging.
  • the eye perfusion and lavage fluid in which the drug solution enclosed in the chamber B further contains at least one, preferably both, calcium ions and magnesium ions, and citrate ions. Bag packaging.
  • the chemical solution enclosed in the chamber B is ⁇ ⁇ 7.0 to 9.0, more preferably ⁇ ⁇ 7.0 to 8.5 Eye perfusion, cleaning solution bag package.
  • An eye perfusion, irrigation solution bag package further comprising a chamber.
  • An eye perfusion / washing solution bag package having a pH of from 3.5 to 5.5, more preferably from 4.0 to 5.0, enclosed in the chamber C.
  • a multi-chamber bag encloses at least one solid agent selected from calcium salts and magnesium salts, preferably a solid agent containing both (hereinafter referred to as “Ca ZMg solid agent”).
  • An eye perfusion, irrigation liquid bag package further comprising a C room.
  • the eye perfusion and irrigation solution formed by mixing the contents of the multi-chamber bag is selected from the following permissible range, more preferably the following preferable range per 100 m 1 Eye perfusion / irrigation solution bag package adjusted to contain components.
  • Ingredients Tolerable range g) Suitable range (g) 'Oxyglutathione 0-0.5 0-0.3 Dextrose 0.4-1.8 0.7-1.65 Sodium bicarbonate 1.5-2.5 1.9-2.3 Calcium chloride (as anhydrous) 0.09 to 0.17 0.1 to 0.15 Magnesium chloride or magnesium sulfate (both as anhydrous)
  • the eye perfusion and irrigation liquid formed by mixing the contents of the multi-chamber bag is selected from the following permissible range per 100 m 1, and more preferably from the following preferable range.
  • An eye perfusion / irrigation solution bag package adjusted to contain components.
  • Ingredients Tolerable range g) Suitable range (g) Oxyglutathione 0 to 0.5 0 to 0.3 Dextrose 0.4 to 1.8 0 to 1.65 to 1.65 Sodium bicarbonate 1.5 to 2.5 1.9 to 2.3 Calcium chloride (as anhydrous) ) 0.09 ⁇ 0.17 0.1 ⁇ 0,15 Magnesium chloride or magnesium sulfate (both anhydrous)
  • An eye perfusion, irrigation solution bag package having a carbon dioxide atmosphere of 0.5 to 20 v / v%, more preferably 1 to 15 v / v%.
  • the solution containing the bicarbonate ion in the pH indicator has a concentration of 0.01 to 2.Ow / v% and the pH indicator has a concentration of 10 to 200 ppm of Creso — Norered, m — Crepe Purple, Timonoreble An eye perfusion, irrigation solution bag package selected from the group consisting of phenol and phenol phthalein.
  • the eye perfusion and irrigation liquid bag package of the present invention is based on the use of a multi-chamber bag having at least two chambers, A and B, for long-term use of oxyglutathione, dextroth and bicarbonate ion solution. Over a period of time.
  • the package of the present invention is based on the fact that the space is made to have a carbon dioxide gas atmosphere, such as by disposing a carbon dioxide-generating type oxygen absorber in the space together with the use of the gas impermeable plastic packaging material.
  • the carbon dioxide gas generated from the bicarbonate ion solution can be prevented from volatilizing into the atmosphere, thereby guaranteeing the advantage that the pH value of the solution can be maintained at a constant value.
  • the package of the present invention also includes a package in which an oxygen detecting agent is disposed in the above-mentioned space. It is possible to easily confirm the problem of oxygen infiltrating into the space, the resulting eye perfusion, the pH change of the washing solution, and the accompanying deterioration.
  • the carbon dioxide gas in the space is based on the use of a solution containing bicarbonate ions as the internal solution of the pH indicator.
  • the pH of the indicator-inner solution also changes in proportion to the pH of the bicarbonate ion solution in the bag, which changes according to the concentration (carbon dioxide partial pressure). Therefore, by detecting the pH change of the internal solution with the pH indicator, the pH change of the bicarbonate solution in the bag can be regarded as the color change of the pH indicator. You can do it.
  • the package of the present invention can avoid the risk of breakage and glass flakes, and can reduce the weight, and can reduce the weight of the normal operation, especially by adopting a configuration using a plastic bag. There is also an advantage that it can be easily manufactured.
  • GSSGZGLU solution or GSSG / GLU solid agent bicarbonate ion solution, and further, if desired, CaZMg solution Or composed of C a ZM g solid Use what is created.
  • the ion and salt concentrations are expressed in the eye perfusion and the rinsing liquid adjusted by mixing the contents (encapsulated material) of each chamber of the multi-chamber bag, unless otherwise specified.
  • salt concentration in terms of anhydride
  • GSSG No GLU solution and bicarbonate ion solution (room filling solution and B room filling solution) contain oxyglutathione and Z or dextroth, and bicarbonate ion as essential components, respectively. And at least one selected from calcium ions and magnesium ions.
  • the bicarbonate ion solution contains at least one selected from calcium ion and magnesium ion, citrate ion is further added to prevent precipitation.
  • At least one kind selected from the calcium ions and the magnesium ions is prepared as a CaZMg solution separately from the GSSGZGLU solution and the bicarbonate ion solution, and is used in addition to the multi-chamber bag. It can be sealed in the room (Room C).
  • composition of each of these components can be determined as appropriate. That is, a mixture of each solution is similar to or slightly similar to the composition of this type of intraocular perfusion and irrigation solution, which has been widely used in the past. It can be changed.
  • Typical examples of the composition of the eye perfusion and the washing solution include those in which the eye perfusion and the washing solution prepared by mixing the respective solutions have the composition ranges described above.o
  • Each of the GSSGGZLU solution, the bicarbonate ion solution, and the CaZMg solution may further contain, for example, ions of trace metals such as phosphorous ion, copper, and zinc.
  • the GSSGGLU liquid contains sodium ion, calium ion, chlorine ion, and the like by adding sodium chloride, potassium chloride and the like.
  • the amount of these components usually ranges from about 0.5 to 0.9 w / v% for sodium chloride, and preferably from about 0.6 to 0.8 w / v%. Often, the range is about 0.02 to 0.05 w / v% for potassium chloride, and preferably about 0.025 to 0.045 w / v%. Desirable.
  • the above-mentioned sodium ion and potassium ion can also be appropriately added to a bicarbonate ion solution and a CaZMg solution.
  • the compound that forms ion bicarbonate to be incorporated in the ion bicarbonate solution may be any of sodium hydrogen carbonate, ammonium hydrogen carbonate, potassium hydrogen carbonate, and other hydrogen carbonate. Are used in the form of an aqueous solution. Also, for example, carbonic acid that produces ionic carbonate such as sodium carbonate and potassium carbonate Even when the salt solution is added as a carbonate, the salt solution produces bicarbonate ion in the pH range of the prepared chemical solution. Can be added to and mixed with bicarbonate ion solution.
  • the concentration of bicarbonate ion in each of these aqueous solutions is not particularly limited, and is usually in the range of about 15 to 5 O mM. This corresponds to a concentration of about 0.1 to 0.4 w / v%, for example, when using an aqueous solution of sodium hydrogen carbonate.
  • a particularly preferred concentration range of the sodium hydrogen carbonate aqueous solution is about 0.16 to 0.16.
  • a compound that generates calcium ion and a compound that generates magnesium ion which can be added to GSSGZGLU solution and bicarbonate solution as appropriate, and can constitute CaZMg solution. May be any of those commonly used in this ocular perfusion and irrigation solutions, for example, chlorides and sulfates of calcium and magnesium.
  • citrate ion is calcium It forms a chelate with on and magnesium ions, and acts to prevent calcium ions and the like from directly binding to carbonate ions.
  • Examples of the compound capable of exerting such an effect include a citrate such as sodium citrate.
  • the compounding amount is usually selected from the range of about 0.35 to 2 w / v% as citrate, and more preferably the range of about 0.5 to: L.2 w / v%. Is good.
  • the bicarbonate solution is usually adjusted to a pH of about 7.0 to about 7.0 using an appropriate pH adjuster, such as sodium hydroxide or hydrochloric acid. It should be adjusted to 9.0, preferably in the range of about 7.0 to 8.5.
  • the liquid may further have a buffering action, for example, sodium hydrogen phosphate, sodium dihydrogen phosphate, calcium dihydrogen phosphate, and potassium dihydrogen phosphate.
  • a buffer such as sodium acetate or potassium acetate can be added, whereby a sharp pH change can be prevented.
  • Such a buffering agent is preferably used at a concentration capable of exhibiting a sufficient buffering capacity when the respective chemicals in the multi-chamber bag are mixed.
  • concentration is, for example, about 0.03 to 0.06 w / v%, preferably about 0.035 to 0.05% for sodium hydrogen phosphate. It is better to choose from the range of w / v%.
  • sodium acetate about 0.02 to 0.06 w / v%, preferably Is preferably selected from the range of about 0.03 to 0.05 w / v%.
  • the GSSG-no GLU solution is usually prepared using the same pH regulator as described above in order to stably maintain oxyglutathione and Z or dextroth in the solution. It should be adjusted in the range, preferably in the range of about 3.0-6.0.
  • a buffer such as sodium acetate / acetic acid bean having a buffering action can be added to the liquid.
  • the CaZMg solution is usually prepared using the same pH adjuster as described above to achieve a pH of about 3.5 to 5.5 in order to reliably prevent the formation of calcium and magnesium or magnesium precipitates. It is desirable to adjust the range, preferably in the range of about 4.0 to 5.0. Buffers such as sodium acetate, potassium acetate, sodium dihydrogen phosphate and dihydrogen phosphate can be added to the solution as described above. .
  • GSSGZGLU solid agent can be used instead of the GSSGZGLU solution.
  • CaZMg solid agent can be used in place of the CaZ'Mg solution.
  • the GSSGZGLU solid preparation must contain at least one selected from oxidaltathion and dexrose.
  • at least one selected from calcium salts and magnesium salts preferably both, can be contained.
  • the CaMg solid preparation can be prepared by using at least one, preferably both, of calcium salts and magnesium salts.
  • Such calcium salts and magnesium salts may be any of those commonly used in ocular perfusion and lavage solutions. Examples thereof include chlorides and sulfates of calcium and magnesium.
  • GSSG GLU and CaZMg solids also include salts of trace metals such as copper and zinc, sodium chloride, potassium chloride, sodium hydrogen phosphate, and phosphorus. It is possible to add sodium salts such as sodium dihydrogen oxide, dicalcium hydrogen phosphate, and potassium dihydrogen phosphate, potassium salts, and phosphate salts. it can. The amount of these additions may be such that the ion concentration in the eye perfusion and the washing solution obtained by mixing them is within the above-mentioned range.
  • These solid preparations may be prepared by mixing the component compounds in a commonly available powder form, for example, to prepare a powder form, and shaping each component mixture according to a conventional method to form fine granules or granules. It can also be adjusted to the form of tablets, tablets and the like. In addition, a solution in which each component is dissolved in water or another appropriate solvent is used according to a usual method. Lyophilized powder obtained by freeze-drying.
  • GSSGZGLU solution GSSGZGLU solid agent, bicarbonate ion solution, CaZMg solution, CaZMg solid agent
  • a product made of polyethylene a product made of ethylene vinyl acetate copolymer, a product made of polypropylene, a product made of polyvinyl chloride, and the like are mixed or mixed in an appropriate ratio. Minutes can be exemplified.
  • the shape, size, thickness and the like of the bag are not particularly limited, and generally a rectangular shape is often used.
  • the content of the bag is generally about
  • the thickness is preferably in the range of about 20 m 1 to about 3 liters, and the thickness is preferably in the range of about 100 to 500 ⁇ .
  • the bag is preferably a gas-permeable plastic bag having at least two chambers having a partition wall which can communicate with the bag. Such bags are already known in the infusion field, for example, provided with means to close the communication between the two chambers.
  • the bicarbonate ion solution may be sealed in at least one chamber of the bag, and the GSSGZGLU solution or GSSG / GLU solid agent may be sealed in at least one other chamber.
  • Gas impermeable in gas impermeable plastic packaging material does not mean strictly impervious to gas, but its gas permeability encloses the above-mentioned eye perfusion and cleaning solution (each solution for that purpose). It means that it is relatively smaller than that of the bag. For example, if the same material as the bag is used but the thickness is large, it can be used as the gas-impermeable plastic packaging material according to the present invention.
  • packaging materials include those commonly used, such as polyethylene terephthalate (PET), polyethylene naphthalate (PEN), polyvinyl alcohol (PVA), and ethylene vinyl alcohol.
  • the shape and size of the packaging material are not particularly limited on the premise that the gas-permeable plastic bag can be accommodated. However, after this storage, a space between the bag and the bag It is preferable that the shape and the size are such that there is a space in which the space can be provided. Generally, the size is about 1.2 to 3 times the capacity of the gas-permeable plastic bag. It is desirable to be.
  • the space between the bag and the packaging material be a carbon dioxide gas atmosphere.
  • a mixed gas of carbon dioxide and air, or a gas mixture of carbon dioxide and nitrogen gas is used as means for setting the space between the bag and the packaging material to a carbon dioxide atmosphere.
  • a method of encapsulating a mixed gas containing carbon dioxide, such as a mixed gas of the above, in the space can be adopted.
  • the carbon dioxide concentration of the mixed gas used is appropriately determined according to the eye perfusion to be filled in the bag, the type of the cleaning solution, particularly the hydrogen carbonate ion concentration and the pH.
  • the aqueous solution when selecting an aqueous solution in which 2.lg of sodium bicarbonate is dissolved in sterile purified water to make a total volume of 1 liter as the above solution, the aqueous solution has a hydrogen carbonate ion concentration of 25 mM.
  • the pH is 8.2, and in order to maintain this value, the carbon dioxide gas concentration in the mixed gas atmosphere is preferably about 0.5 to 20%.
  • the partial pressure of carbon dioxide in the space is Usually, it is preferably adjusted to a range of about 1 mmHg to 250 mmHg, and it is preferable to select the content ratio of carbon dioxide in the mixed gas according to this. More specifically, when the pH of the manufactured bicarbonate ion solution is within a predetermined range, the carbon dioxide gas sealed in the space should be substantially equal to the carbon dioxide partial pressure of the chemical solution. I just need.
  • the space between the bag and the packaging material into a carbon dioxide gas atmosphere
  • oxygen gas existing in the space is absorbed, and the absorption amount is fixed to the amount of absorption.
  • Means for enclosing a carbon dioxide-generating type oxygen scavenger that releases carbon dioxide gas in a certain volume in the space may be mentioned.
  • the carbon dioxide-generating type oxygen scavenger include “Ageless G” manufactured by Mitsubishi Gas Chemical Co., Ltd. and “Ageless GMJ” and C type freshness preservative manufactured by Toppan Printing Co., Ltd. These can be used by enclosing them in the above-mentioned space as they are usually obtained.
  • ocular perfusion, filling of a bag with a washing solution, sterilization, packaging with a packaging material, and the like can be easily performed in the same manner as in a usual method for producing an injection solution.
  • the package has a space between the multi-chamber bag and the packaging material in a carbon dioxide gas atmosphere, and the space has an oxygen atmosphere. Detection The agent is located.
  • the oxygen detector when the package of the present invention is stored for a long period of time or when a pin pole occurs in the packaging material, carbon dioxide gas leaks from the space, troubles of oxygen intrusion, eye perfusion due to this, especially Changes in the pH of the washing solution and deterioration of the drug can be easily confirmed, and thus eye perfusion and the safety of the washing solution can be guaranteed.
  • the oxygen detector used is capable of reacting only to oxygen gas and clarifying its existence by discoloration or the like and not reacting with other gases.
  • Examples of commercially available examples include “Ageless Eye CSJ” manufactured by Mitsubishi Gas Chemical Company, Ltd.
  • the oxygen detector can detect the presence of a relatively small amount of oxygen, it is desirable that the oxygen concentration in the space be as low as possible when the oxygen detector is used in the present invention. Good.
  • the oxygen concentration is desirably about 0.5 v / v% or less.
  • the means include a method in which the space is replaced with a mixed gas of carbon dioxide and an inert gas, and an appropriate method such as the above-described carbon dioxide-generating type deoxidizing agent in the space. It is possible to adopt a method of arranging and enclosing a suitable oxygen absorber.
  • the space between the multi-chamber bag and the packaging material is provided with a carbon dioxide gas atmosphere.
  • a pH indicator in which a liquid containing bicarbonate ions and a pH indicator that changes color according to the pH change of the liquid are enclosed in a small gas-permeable plastic container in the space. Is arranged.
  • the concentration or composition of the pH indicator internal solution is not particularly limited as long as it contains bicarbonate ions.
  • the bicarbonate ion concentration is usually preferably selected from the range of 0.01 to 2.0 w / v%.
  • the pH indicator to be added to and mixed with the indicator solution can be selected from various acid-base indicators capable of controlling the pH change of the indicator solution by color change.
  • the color tone is sensitive to the bicarbonate-containing chemical solution enclosed in the bag, near the pFI region of the above solution in the indicator at the equilibrium carbon dioxide gas rate in the space corresponding to the pH. It is preferably something that changes (discolors).
  • the pH in question is in the weak alkaline region above neutral as described above (for example, the upper limit of the standard for a 7% aqueous solution of sodium hydrogencarbonate is pH 8.6 in Japan Pharmaceutical XIII).
  • the carbon dioxide gas rate is about 19%), and the proportional pH of the indicator solution is also in the neutral to weak alkaline range (for example, 0.28% sodium bicarbonate). Since the pH indicator of an aqueous solution is 7.0), the pH indicator It is preferable that the color change in the rear area.
  • Particularly preferred PH indicators include (1) a narrow discoloration area, (2) a high color intensity, and (3) an appropriate direction of discoloration (from an inconspicuous color to a conspicuous color). (4) Good hygiene (high safety of the substance itself and no migration), (5) Good stability and retention of initial discoloration ability over a long period of time. It is better to select from those having properties.
  • Such conditions include, for example, Neutral Red, Adrien, Phoenix Red, o—Creative Red, ⁇ —Naphtal Red, m—cresol no.
  • Neutral Red Adrien
  • Phoenix Red Phoenix Red
  • o—Creative Red ⁇ —Naphtal Red
  • m cresol no.
  • One pull, orange I, timo-no-reble, and phenol-terrain can be exemplified.
  • phenol red color changes from yellow to red at pH 6.8 to 8.4
  • o-cresone red pH yellow at pH 7.2 to 8.8
  • m-cresorno m-cresorno
  • ° punoré colored from yellow to purple at pH 7.6-9.2
  • Thymol Bleu diol phthalein
  • phenol phthalein pH 8.3-: discolored from colorless to red by LO
  • the concentration of the above pH indicator may be any as long as the color tone change is easy to visually observe. It is preferable to select from the range of about 10 to 2000 ppm depending on the size (the thickness of the liquid layer) of the small container sealed together with the internal liquid.
  • the gas permeable plastic small container enclosing the above solution and the pH indicator can be manufactured according to a general method, and the material of the container used at this time is the same as that of the bag described above. Any material having gas permeability higher than that may be used.
  • the above small containers are a vertical three-side sealing machine, a vertical pillow wrapping machine, and a mouth lino Reno. It can be manufactured by a method that performs bag making, filling, and sealing continuously using a marker or the like. When such a method is used, it is preferable that the material of the small container is a laminated film from the viewpoint of machine suitability, especially when the bag is made of polyethylene.
  • the volume of the La value only one walk Lee's are those prepared by Lum is preferred correct the c the small container size and internal solution, when encapsulating ⁇ the small vessel, the amount of internal liquid If the amount is small, the thickness of the liquid layer of the indicator becomes too thin, and the color tone change tends to be difficult to visually discriminate. Bags and packaging It can be determined as appropriate in consideration of the size and the like.
  • the pH indicator thus produced may be turbid due to the growth of bacteria in the internal solution during long-term storage, and high-pressure steam sterilization is performed to prevent or suppress this. You can.
  • a bactericide such as benzonal conidium chloride or chlorhexidine gluconate, an antibacterial agent such as nalidixic acid, norrefloxacin, or a preservative such as paraoxybenzoate or benzyl alcohol may be appropriately used. It can be added and blended.
  • the small container can be placed (enclosed) in the space simply by packing the bag and the small container together in a packaging material.
  • a packaging material There is no particular limitation as long as it can be seen from the outside even after the packaging by.
  • the package of the present invention comprises a bicarbonate ion solution and a GSSG / GLU solution (content solution). , 1 and 1) in each of the compartments defined by the weak seal section 6-a gas-permeable plastic multi-compartment bag 2 enclosed in each, a gas-impermeable plastic in which the bag is packaged It is placed in the packing material 3 and in the space 4 between the bag and the packing material.
  • the space indicator is made of a carbon dioxide gas atmosphere.
  • FIG. 1 is a schematic view showing an embodiment of the eye perfusion and washing solution bag package of the present invention.
  • 1 is an eye perfusion and washing solution
  • 2 is a gas-permeable plastic double-chamber bag
  • 3 is a gas-impermeable plastic packaging material
  • 4 is the bag 2 and the packaging material 3 described above.
  • 5 shows a small container made of gas-permeable plastic (pH indicator)
  • 6 shows a weak seal portion of a multi-chamber bag made of gas-permeable plastic.
  • aqueous sodium hydrogen carbonate solution was added to and dissolved in phenolic red lO mg to make 5 OO ml (20%). w / v ppm).
  • 0.5 ml of this product is pol- ylene (outside, thickness: 20 m) and polyethylene (inside, thickness: 30 zm) by a vertical three-way sealing machine. It was sealed in a laminate finolem to obtain a pH indicator with a length of 30 mm and a width of 15 mm (inner size). It had a purple-red color (colored) at the time of manufacture.
  • a 0.28% aqueous solution of sodium hydrogen carbonate was added to 10 mg of Creso-Relex to dissolve it to give 500 mL (20 w / v ppm). 0.5 m] of this is sealed in a polystyrene film (Mitsui Petrochemical Co., Ltd., thickness: 250 zm) and the pH of 40 mm in length and 20 mm in width (inside dimensions) I got an indicator. It was purple (colored) at the time of manufacture.
  • poly 4-methyl 1-pentene (outside, thickness: 30 ⁇ m) and polyethylene (inside, thickness: A pH indicator was produced in the same manner as in Production Example 5 using the laminated film of 60 m).
  • This product was excellent in high-speed sealing performance and higher in productivity because of its high heat resistance of poly-4-methyl-1-pentene.
  • laminate it with nylon (thickness: 15 m), polyvinyl alcohol (thickness: 18 m), low-density polyethylene (thickness: 60 / im)
  • a bag made of finolem was sealed and stored together with a mixed gas of 10% carbon dioxide and 90% air.
  • a pinhole (major axis: approx. 5 mm) was applied to each packaging material of the eye perfusion and washing solution bag package of the present invention produced in each of Examples 1 and 4 using a syringe needle (27 G, Terumo, Neoras). 0 / m, minor axis: about 50 / zm), and the discoloration of the pH indicator was observed.
  • the pH indicator turned green.
  • cleaning liquid is stably accommodated in the plastic double-chamber bag, and the eye perfusion and washing

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  • Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Hematology (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Packages (AREA)
  • Detergent Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Cleaning Implements For Floors, Carpets, Furniture, Walls, And The Like (AREA)
  • Medicinal Preparation (AREA)

Abstract

L'invention concerne un sachet de perfusat ophtalmique et de fluide nettoyant conditionné, lequel comprend un sachet à double compartiment plastique perméable au gaz et une matière de conditionnement plastique imperméable au gaz pour le sachet, et dans lequel une préparation liquide ou solide contenant de l'oxyglutathione est contenue dans un compartiment tandis qu'un second compartiment renferme une solution d'ion bicarbonate, un espace situé entre le sachet et la matière de conditionnement étant rempli de dioxyde de carbone.
PCT/JP1998/004814 1997-10-27 1998-10-23 Sachet de perfusat ophtalmique et de fluide nettoyant conditionne WO1999021527A1 (fr)

Priority Applications (6)

Application Number Priority Date Filing Date Title
DE69840003T DE69840003D1 (de) 1997-10-27 1998-10-23 Verpackung mit ophtalmischen perfusat und reinigungsflüssigkeit
CA002307162A CA2307162C (fr) 1997-10-27 1998-10-23 Sachet de perfusat ophtalmique et de fluide nettoyant conditionne
EP98950367A EP1033124B1 (fr) 1997-10-27 1998-10-23 Sachet de perfusat ophtalmique et de fluide nettoyant conditionne
US09/530,507 US6764481B1 (en) 1997-10-27 1998-10-23 Packaged ophthalmic perfusate and cleaning fluid bag
HK01100886A HK1033257A1 (en) 1997-10-27 2001-02-08 Packaged ophthalmic perfusate and cleaning fluid bag.
US10/735,639 US7047708B2 (en) 1997-10-27 2003-12-16 Method of packaging ocular irrigating solution

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
JP9/294310 1997-10-27
JP29431097 1997-10-27
JP31308397 1997-11-14
JP9/313083 1997-11-14

Related Child Applications (3)

Application Number Title Priority Date Filing Date
US09/530,507 A-371-Of-International US6764481B1 (en) 1997-10-27 1998-10-23 Packaged ophthalmic perfusate and cleaning fluid bag
US09530507 A-371-Of-International 1998-10-23
US10/735,639 Division US7047708B2 (en) 1997-10-27 2003-12-16 Method of packaging ocular irrigating solution

Publications (1)

Publication Number Publication Date
WO1999021527A1 true WO1999021527A1 (fr) 1999-05-06

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EP (1) EP1033124B1 (fr)
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KR (1) KR100381326B1 (fr)
CN (1) CN1187031C (fr)
AT (1) ATE407652T1 (fr)
CA (1) CA2307162C (fr)
DE (1) DE69840003D1 (fr)
ES (1) ES2313753T3 (fr)
HK (1) HK1033257A1 (fr)
WO (1) WO1999021527A1 (fr)

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ES2313753T3 (es) 2009-03-01
US6764481B1 (en) 2004-07-20
EP1033124B1 (fr) 2008-09-10
KR100381326B1 (ko) 2003-04-23
KR20010031451A (ko) 2001-04-16
US20040123563A1 (en) 2004-07-01
ATE407652T1 (de) 2008-09-15
CN1277547A (zh) 2000-12-20
CA2307162A1 (fr) 1999-05-06
CA2307162C (fr) 2006-03-21
CN1187031C (zh) 2005-02-02
EP1033124A4 (fr) 2004-04-14
US7047708B2 (en) 2006-05-23
JP3060133U (ja) 1999-07-30
HK1033257A1 (en) 2001-08-24
DE69840003D1 (de) 2008-10-23
EP1033124A1 (fr) 2000-09-06

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